The approval is supported by strong preclinical data demonstrating MP1032's capacity to sustain muscle function.

The designation was based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.

European Medicines Agency recognizes potential of lead compound MP1032 in addressing a high unmet medical need in Duchenne Muscular Dystrophy (DMD)Designation is paving the way for safer long-term ...

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

The European Medicines Agency (EMA) cleared the way for the use of another drug to treat Alzheimer's disease on Friday.

Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug ...

ImCheck’s Announces EMA Orphan Drug Designation for ICT01 as Treatment for Acute Myeloid Leukemia Following the FDA ODD, European designation underscores ICT01’s potential as a novel immunotherapy ...

CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumor cells. When administered with a ...

Contacts Media Relations: +1 (212) 733-1226 [email protected] Investor Relations: +1 (212) 733-4848 [email protected] Industry: Biotechnology FDA Health Pharmaceutical Clinical Trials ...

This new Shingrix vaccine presentation eliminates the need for reconstitution, simplifying the administration process for healthcare professionals.

Drug regulators in the European Union (EU) are sticking to their recommendation to suspend the sale of dozens of generic drugs because of flawed clinical trials conducted in Hyderabad, India ...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for ritlecitinib for adults ...